Table 2

Validation of surrogate end points (relationship of surrogate end point to disease, effect of drug intervention on surrogate end point, effect of drug intervention on disease): cholesterol lowering and CHD

Association of cholesterol level and CHD from Framingham study, data for total population (84) :
Serum CholesterolRelative Risk (Observed/Expected × 100)
1st Quartile (≤ 193 mg/100 ml)57
2nd Quartile85
3rd Quartile102
4th Quartile (≥ 250 mg/100 ml)152
Effect of drug intervention on cholesterol level, leading to approval by FDA for prevention of CHD (cited in Ref. 56 )
Simivistatin decreased serum cholesterol averaging 26% compared with placebo controls.
Effect of cholesterol lowering intervention on CHD, meta-analysis of trials ≥2 yr in duration (56)
For every 10% cholesterol lowering, CHD mortality reduced by 13% (P < 0.002) and total mortality reduced by 10% (P < 0.03).